BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3200373 · Received July 1, 2013

    Report

    Report Number
    1644487-2013-02001
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT A VNS PATIENT HAD AN INFECTION. FOLLOW-UP SHOWED THAT THE INFECTION WAS FIRST OBSERVED ON (B)(6) 2013. THE ENTIRE SYSTEM WAS REMOVED ON (B)(6) 2013. THE RELATION OF INFECTION TO VNS WAS UNKNOWN. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE INFECTION. THE INFECTION WAS AT THE GENERATOR AND LEADS. CULTURES OF THE FLUID AROUND GENERATOR GREW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300236 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202009

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention